Natural medicine advocates believe the public’s fundamental basic human right of choice is under attack.

Currently, more than 100 countries regulate herbal medicines in varying degrees, as countries attempt to protect their populations from counterfeit and poor quality or adulterated herbal products. Safety concerns have focused on the powerful effects of some herbal remedies andn the way they interact with conventional drugs (4). For example, St John’s Wort can interfere with some contraceptive pills, while ginkgo and ginseng are known to have a similar effect when used with the blood-thinning drug Warfarin (3).

The European Union’s Traditional Medicinal Products Directive, originally passed in 2004, and effective as of April of 2011, is meant to regulate the sale of herbal medicinal products online and in-store. Under the EU law to qualify as a “long-established traditional medicine,”products must have been in use for the past 30-years (15-years within the EU in general). The enforcement of this law not only handicaps innovation within the natural health industry, but effectively eradicates all herbal medicines (i.e Chinese, Western, and Ayurvedic) and any other medicinal herb from the European Union as well as the United Kingdom. Under these standards, regulation limits access to only pharmaceutical drug-based treatments.

Numerous professionals have voiced their indignation as this regulation does away not only with products, but with the practitioners themselves! The natural health care community is concerned with establishing a distinction between charlatans and professionals in industry just as much as the need to distinguish counterfeit products from products based on sound science. However, this April, 2011 EU solution sacrifices natural medicinal product and practitioner as well as the individual’s right to choose!

Reaction

In France, a petition against the directive has been launched by a group of natural remedy stakeholders calling itself ‘Le Collectif por la Defense de la Medecine Naturelle’. Dr. Robert Verkerk, executive and scientific director of the UK-based Alliance for Natural Health, said: “The problem is that [synthetic chemical ingredients] are deemed necessary by formulators in order to meet the pharmaceutical stability standards set by the EU directive. Forcing non-European herbal traditions into a straitjacket would effectively corrupt these great traditions (1)”. There is real and growing concern that many valued herbal remedies which have been around for thousands of years will simply cease to be available to the public(6).

On the Home Front

The US is gradually incorporating greater restrictions through manufacturing regulations set by the Food and Drug Administration (FDA). These regulations sometimes lack adequate definitions in establishing appropriate criteria to accept or exclude products from the market. Legal challenges have proved the agency’s need to redefine and reconsider a new approach when enacting restrictive policy and have made considerable gains in re-establishing certain positive parameters in natural health care.

Pearson v. Shalala I -1998

The US Congress authorized the FDA to pre-approve health claims on foods (including dietary supplements). In fact, the FDA had only approved ten claims during the ten years that followed due to the undefined and difficult standards set. Dirk Pearson and Sandy Shaw, supplement manufacturers, sued the FDA in federal court for refusing to allow four health claims on their products which they argued were supported by science. Their premise was based on the First Amendment and the FDA’s failure to define their standard for accepting a health claim (10). The D.C. Appeals Court stated:

We agree with appellants that the [Administrative Procedures Act] requires the agency to explain why it rejects their proposed health claims—to do so adequately necessarily implies giving some definitional content to the phrase “significant scientific agreement.”...It simply will not do for a government agency to declare—without explanation—that a proposed course of private action is not approved...“The agency must ... articulate a satisfactory explanation for its action....To refuse to define the criteria it is applying is equivalent to simply saying no without explanation (9).

Pearson v. Shalala II -2000

Late 2000 saw Pearson return to court filling another lawsuit against the FDA arguing the health claims that adequate intake of folic acid by pregnant women could prevent neural tube defects. The court stated

It is clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson I. ...Additionally, the FDA’s conclusion that the ‘weight’ of the evidence was against Plaintiffs’ Folic Acid Claim was arbitrary, capricious and otherwise in violation of law (9).

Enough is Enough

The Association of Natural Health believes public safety is a shared concern for all professions. The ethical principle and oath “to do no harm to human life” is driven by the individual and collective well-being of our society.

We at the AONH acknowledge the importance of both traditional and western medicines. Neither should be discarded when the primary objectives are the restoration of health and the prevention of illness. The challenges we face today offer a unique opportunity for us to take part in directing the course our governments take in writing policy. As proven by other countries which utilize both natural and allopathic medicines effectively, integration of natural medicine can prove to be the backbone of primary care in working alongside conventional medicine in a safe, efficient, regulated manner.

As we begin 2012, let us strengthen our resolve to advocate natural health care through education, encouragement and support. There are many ways to support our cause. Your membership entitles you to benefits, but also places shared responsibility to crusade for effective policy on your shoulders. Please continue to do so by supporting the AONH, and like organizations, in the battle for freedom of choice.

NBC correspondent Chris Hansen’s Dateline episode aired on March 18th, 2012 and focused on the lack of regulation for the nutritional supplement industry. It was advertized as a “shocking expose.” The story focused on a specific case regarding a liquid vitamin/mineral supplement which was distributed and sold in stores in Georgia, Alabama and 15 other states. Consumers who took it experienced adverse effects including, but not limited to, complete hair and fingernail loss. Investigations into the contents revealed the supplement, Total Body Formula, contained very high levels of selenium.*

As part of the undercover investigation, Dateline asked a laboratory that provides testing for the supplement industry to test two products for purity. Both had been laced with dangerous substances and did not include the ingredients that were supposed to provide health benefits. The undercover investigators told lab officials they planned to begin marketing the products and wanted an accurate test to ensure they were safe for human consumption. Hansen said. “The lab did not detect the lead and arsenic we had spiked the product with, nor did it pick up on the absence of active ingredients. If we were actually going to market the product, the certification we received from that lab would have allowed us to do so (6).”

With this article we, at AONH, wish to convey that shortcuts arising form negligence or a desire for profit should never be taken as they compromise our safety and tarnish the supplement industry. We strive to educate by raising awareness, conveying both good and bad news tactfully to our readers who in turn, make informed decisions. We denounce, however, the media’s use of the fear-factor to undermine the credibility of an entire industry classifying it as unsafe for the sake of a story. Each unfortunate case that arises should serve to strengthen our resolve to protect our trade and we should seize the opportunity this propaganda presents to learn the rest of the story and communicate it to others.

The Rest of the Story

“For years...Wright Labs produced without incident, the vitamin premix blend component of the Total Body Formula. In 2007, apparently for cost cutting reasons, Total Body Essential Nutrition, Inc. (the distributor) changed its product manufacturer to a company named Texamerican Food Blending, Inc. without Wright’s knowledge (6).”

As reported by the FDA, two batches of the supplements marketed and distributed from January 2008 through late March 2008 contained about 300 times the U.S. recommended daily requirement of selenium (6).

“When Wright Enrichment tested the blend at its laboratory, the tests showed an excessive amount of selenium. Wright’s quality assurance director reportedly asked the laboratory director to change the certificate of analysis to reflect the quantity of selenium that the blend should have had. When the lab director refused, the quality assurance director allegedly changed the certificate himself.”

Total Body argued it was merely the distributor, not the manufacturer, relying on others to manufacture a safe product. TexAmerican argued it hired Wright Enrichment to produce the blend, that attempted to cover up their flawed processes. Wright Enrichment argued that TexAmerican sent it erroneous information regarding what the product was supposed to contain (4).

In 2011 Headlines read “A Florence law firm won a $2 million judgment for a client sickened by a dietary supplement.” The jury awarded $2 million, allocating liability at 70 percent to Wright Enrichment, 20 percent to TexAmerican, and 10 percent to Total Body (4).

Back to Dateline

Hansen stated

“there is no scientific protection for users of dietary supplements. You can make a nutritional supplement without having to collect scientific data to back up your claims..., and you can cook it up in your back yard (3).”

Surely, it is expected for a public figure to be informed before berating the entire industry. These statements are a far cry from the whole picture. Firstly, Hansen’s statements undermine the efficacy and the competence of the FDA. Secondly, Hansen appears to have completely ignored the FDA’s efforts to regulate the supplement industry and its proposed Draft Guidance parameters. Lastly, even after Pearson v. Shalala (which argued the allowance of qualified product health claims) in 2000, the number of approved claims is extremely low.

Rather than upset the public with distorted propaganda AONH proposes to be proactive. We must play a part in the enactment of legislation aimed at regulating our industry.

A good example of this is the role of the American Herbal Products Association. The AHPA is a body of growers, processors, manufacturers and marketers of herbal products which called for the withdrawal of the FDA’s nebulous Draft Guidance and issuance of a new guidance consistent with the Dietary Supplement Health and Education Act (DSHEA). The AHPA stated,

the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive and pharmaceutical type evaluative criteria, require multiple [New Dietary Ingredient] NDI notifications for dietary supplements beyond those required by law, and transform the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process (7).

Clearly, this would be an example of over-regulation under any standards, sharply contrasting Mr. Hansen’s layperson opinion.

What were the results? Senators Orrin Hatch (R-Utah), and Tom Harkin (D-Iowa), principal authors of the Dietary Supplement Health Education Act of 1994, addressed the FDA in a letter urging the withdrawal of the NDI Draft Guidance. Their request hopes to bring forth issuance of a new draft that will “provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck…to provide consumers with access to safe, affordable dietary supplement products (5).”

Dateline’s “expose” appears synchronized with the current struggle faced by the supplement industry. On the heels of the recent banning of many natural supplements in Europe, could the same happen here? Could we lose our access to supplements, and most of all our freedom to choose for ourselves?

Sensationalist media, however, provides an opportunity. We can now be proactive and share our side of the story. Where there is truth in NBC’s investigation, the story is incomplete and does not encompass the entire industry. Let us wash away the after taste of fearing the unknown with a libation of truth by promoting awareness of ourselves and the professions we represent as stalwarts of a safe supplement industry.

*Selenium is a tolerable “trace” mineral conducive to good health small quantities. High-level exposure may lead to brittle hair, deformed nails, and an increased risk of type II diabetes.

Draft Guidance Still in the Balance

The European Union’s ban, which went into effect May 1, 2011, appeared to foreshadow the direction American legislators were considering going in. A comparable draft guidance proposed by the FDA sparked a deep concern from the supplement industry and American citizens, as their right to choose their own health care was in question. This collective outcry was heard as one voice, prompting the FDA to draft a revised version of its guidance addressing the salient issue regarding new dietary ingredients (NDIs).
Senators Orrin Hatch (R-UT) and Tom Harkin (D-IL) played a pivotal role during this process and have raised the hopes of thousands by requesting greater clarity in definitions and parallel adherence to the original statute regarding herbal supplements. Steve Mister, president and CEO of the Council for Responsible Nutrition, said the FDA plans to address all five of the substantive issues raised by several associations including the Natural Product Association, the American Herbal Product Association, and the United Natural Products Association (4). The five issues are outlined as follows:

● Whether a synthetic version of a botanical ingredient can be a botanical ingredient.
● Grandfathered ingredients, and who has the burden to prove something is grandfathered.
● Whether an NDI has to be filed for each supplement or whether it can be filed with the ingredient itself.
● The breadth of the definition of chemical adulteration. As Mister explained, “The broader that is, the more ingredients that get caught up in the NDI issue and the fewer ingredients that are considered old.”
● What is the appropriate standard of science to match the “reasonable standard of safety”?

Addressing these five issues could mark the beginning of a positive outcome, as desired by the various sectors of the supplement industry as well as the FDA. It underlines the power of a united voice in a ripple effect through which constituents and industry shape our legislation. This aforementioned power is not only heard as a voice advocating freedom of choice in health care and accessibility to herbal supplements, but also reveals the tremendous impact the supplement industry has on our country’s economy.

The Industry Impact

A recent study funded by the Natural Products Foundation has found the total contribution of the supplement industry to the U.S. economy is 61 billion dollars per year. The study also showed that the supplement industry has enough activity throughout production and sales to support more than 450,000 jobs (2). These findings corroborate the industry’s importance by quantifying its overall financial impact on the national economy by considering such contributing factors as supply, production, research, direct employment, manufacturing, taxes, and the extended financial effects these factors produce (2). The supplement industry represents an important component of the US economy, inevitably interconnected with many other industries.

executives with companies selling everything from energy drinks to weight-loss pills made from African mango-seed extracts are among the ranks of Republican Mitt Romney’s top fundraisers (5).” The FDA’s draft guidance does not exclusively affect Democrats or Republicans, but is rather an issue which challenges each American’s rights. The article continued “unlike the pharmaceutical industry, supplement makers long have been exempted from federal review of their products for safety or effectiveness before being marketed (5).

The term “exempt” is misleading and false, contrary even to recent reports published in the Chicago Tribune detailing widespread shortcomings of dietary supplement manufacturers inspected by the FDA. David Schardt, a senior nutritionist with the Center for Science in the Public Interest expressed “it [the supplement industry] is viewed as a Wild West arena, where virtually anything goes (5).” Interestingly enough, the article later describes, “The industry now is pushing the FDA to rescind what it claims are overly broad regulations proposed last year on new supplement ingredients. The proposal seeks to comply with a 1994 law that declared anything already sold as a supplement was considered safe, but said new ingredients introduced after that date would be subject to FDA scrutiny before being marketed (5)” – a far cry from the “exemption” mentioned previously.

Sweeping Claims

In response to a Chicago Tribune article which was critical, at best, of supplement manufacturing standards, Senators Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn. sent letters to three major supplement organizations asking them to spell out their plans to improve conditions in the supplement industry (7). In a letter addressing Blumenthal, NPA executive director and CEO John Shaw wrote, “NPA believes the FDA’s reckless comments in the Chicago Tribune article distort the full picture of our membership’s overall safety record. In fact, supplements have an excellent safety record, but we appreciate this opportunity to provide more information to you (6).” In a separate letter to Durbin, Steve Mister, CRN president and CEO cautioned the senators against making premature conclusions based on the FDA’s report that 1-in-4 dietary supplement companies warranted a warning letter following an inspection. This is false, as the FDA concentrates its enforcement efforts on companies already suspected of being in violation of cGMPs, rather than a random sampling of the entire supplement industry and as such, not representative of firms in full GMP compliance.

Michael McGuffin, president of the American Herbal Products Association (AHPA), met with senator Durbin’s staff members to discuss the senator’s recently expressed concerns about the supplement industry’s compliance with current good manufacturing practices (cGMPs). McGuffin restated a learning curve is expected when a manufacturing rule is revised, and drew an example from an FDA report that just 54 percent of seafood companies were in compliance with the new manufacturing rule issued for that industry five years after it was established in 1997 (1).

A Long Road Ahead

Even though the FDA has agreed to revise the draft guidance, there is still a lot of work ahead. The media continues to publish unfounded sensationalism, which is perceived as fact by readers. We should expect to read more about the supplement industry in the coming months, as candidates continue their campaigns.

Now more than ever we are called to be informed, and inform others. Published statistics can be interpreted in different ways. Not knowing which method was used in conducting the study nor considering the specificity and the reliability of the study invalidates the extrapolation of results. In this case, a number of supplement firms failing to comply in manufacturing requirements does not represent the industry, but can influence the reader and evoke reactions akin to those of senators Durbin and Blumenthal.

Our voices have been heard, but we must continue on our mission as advocates of health, choice, and freedom.

Good Manufacturing Practices (GMP)
Under Scrutiny

It seems the FDA has shifted its attention. It was firmly on the proposed New Dietary Ingredient (NDI) Draft Guidance and now appears to be tackling good manufacturing practices (GMP) violations in the supplement industry.

“the FDA conducted 175 GMP inspections in 2011, more than double the 84 conducted in the previous year.”

Field inspections are only expected to increase as the agency targets GMP violators. Numerous warning letters have been issued to manufacturers failing to meet set standards. Such inspections may be the first step in clearing the name of responsible manufacturers. This is a positive step in holding manufacturers accountable. The media has tarnished the industry with blanket statements based on a few instances specific to certain manufacturers’ violations. John Shaw, executive director of the Natural Products Association stated,

“We face a constant barrage of media stories questioning the benefits of our products. We must anticipate news cycles and seize teachable moments in the media to drive our overall agenda (1). ”

Last year’s FDA’s acceptance to revise its draft guidance was met by the natural products manufacturing community with gratifying relief. They welcomed this action praising it as a partial victory in response to the concerns the draft raised initially. The verbiage was full of conflicting terminology and extremely general definitions, which is why many such as Loren Israelsen, director of the United Natural Products Alliance (UNPA) believe determining the accurate definition is key to resolving industry concerns (1). Starting with the term new dietary ingredient (NDI) and whether it applies to a single substance or a finished product. While the FDA’s revision to the supplement draft guidance is completed, related topics are at the forefront of local and international agendas.

Last month the Alliance of Natural Health represented US consumers at the International Codex Committee on Nutrition and Foods for Special Dietary Uses in Germany. The Codex is an international guideline, or accepted model, that will likely be followed by federal agencies, on a global scale, as they develop their own regulations in their respective countries. The meeting raised several issues including mandatory labeling of Genetic Modified Organisms (GMOs) and retention of access to dietary supplements in high-nutrient-level dosages. During this meeting, committee members emphasized language indicating that food prevents disease is forbidden –and they are opposed to claims that may “mislead” even if the claim is true (5). The US delegation disagreed, stating, “While we have similar policies about food claims, by definition the nutrients in food prevent nutrient-related diseases (5)”.

The Codex committee adopted extremely low nutrient reference values for labeling purposes. These are far too low to be effective in preventing disease, according to most natural health experts, with even higher nutrient values needed to optimize health. It was stressed, the actual values weren’t important because they are “just for labeling purposes.” This of course, matters to us in terms of how it resonates with supplement dosage regulation. Whether or not the US adopts these values is to be determined at a future time, but differing values would create trade barriers between nations.

While a country may not be obligated to adopt a Codex standard into domestic law international trade pressures from powerful countries create political and economic pressure to do so. Access to high-level nutrients is not equal in all nations, but restricted to developed nations.

GMO acceptance is varied across borders, as some nations are more receptive to admission of such on store shelves. As of now, a decision on banning, or allowing, GMOs was not reached for “lack of science” though there were many to voice their support for GMOs. Europe is not as GMO-friendly as the US, and this in itself already impedes trade. As such, setting up an international gold standard for labeling GMOs is a significant challenge.

Efforts requiring GMO labeling have been rekindled after last year’s initial rejection of a bill that would have required labeling for genetically modified food in a similar initiative in the state of Washington. Advocates of labeling requirements say the products have been a concern, in part, because the inserted DNA sometimes comes from animals, bacteria and viruses, not plants. Even plant sources pose a risk as cross-pollination from GMO plants to non-GMO crops could potentially lead to genetic mutations (3). If Washington’s initiative (I-522) were rejected, it would be sent to the general ballot or pass an alternative, which would send both the initiative and the alternative to voters later this year (6).

There is clear evidence of growing pressure in vocal support of mandatory GMO labeling. This is largely because it is in the best economic interests of states in which unlabeled GMO wheat, apples and salmon could damage agricultural exports to countries that either forbid or require GMO labeling. Despite public opposition to genetically engineered salmon (the fish is designed to grow five times faster than normal and could be linked to food allergies!) the FDA announced in late December it would allow its commercialization.

In Alaska, GMO salmon must be labeled due to a state law passed in 2005. This exemplifies the impact voters can have on their state legislatures and perhaps the beginning of a ripple effect to neighboring states that might adopt the same policies thereby increasing the pressure on a national level.